Table 3.
Effects of 4 Weeks of Mirtazapine, 15 mg, on Polysomnographic Indexes and Sleepiness, Compared with Placebo: Study 2
| Outcome Variable | Baselinea |
Change while on treatmentb |
||||
|---|---|---|---|---|---|---|
| Placebo | Mirtazapine | Mirtazapine + CD0012 | Placebo | Mirtazapine | Mirtazapine + CD0012 | |
| AHI, no./h | ||||||
| Total | 27.4 (11.1) | 23.7 (9.8) | 23.6 (10.8) | −3.7 (5.4) | −5.0 (3.2) | −4.3 (2.2) |
| Apneas | 7.4 (7.0) | 5.6 (6.2) | 8.1 (10.4) | −3.5 (3.2) | −5.5 (2.2) | −3.5 (1.5) |
| Hypopneas | 19.1 (9.5) | 17.8 (7.7) | 15.1 (8.3) | −0.4 (5.1) | 0.6 (2.1) | −1.1 (2.2) |
| In REM sleep | 28.1 (19.7) | 25.9 (19.0) | 34.6 (20.1) | −3.5 (5.9) | −7.2 (6.2) | 1.3 (4.2) |
| In NREM sleep | 28.2 (12.4) | 24.1 (11.7) | 21.4 (11.5) | −5.4 (6.2) | −4.3 (3.3) | −5.6 (2.3) |
| Sleep efficiency, % | 77.5 (10.4) | 78.4 (9.6) | 75.3 (12.9) | 7.4 (1.8) | 2.8 (4.3) | 4.6 (3.2) |
| Sleep stage, min | ||||||
| SWS | 53.1 (38.7) | 71.5 (27.2) | 59.5 (29.5) | 23.3 (11.0) | 15.2 (10.1) | −6.4 (6.3) |
| REM | 71.4 (28.1) | 69.3 (26.3) | 61.3 (30.3) | 13.0 (3.4) | 2.6 (5.8) | 6.4 (6.9) |
| Stage 1&2 | 240.7 (27.2) | 222.3 (47.1) | 231.1 (36.2) | −17.9 (16.0) | −2.2 (17.2) | 20.9 (12.0) |
| ESS score | 11.1 (2.2) | 12.1 (3.5) | 13.1 (2.7) | 1.3 (1.4) | 3.3 (0.7) | 0.3 (1.1) |
a
Data are presented as mean (SD).
b
Data are presented as mean (SEM).
AHI refers to apnea-hypopnea index; NREM, non-rapid eye movement sleep; ESS, Epworth Sleepiness Scale.
Baseline values in those who completed the protocol. Figures in the improvement columns are positive numbers when that index improved and negative when that index worsened. Positive figures for slow wave sleep (SWS), rapid eye movement sleep (REM), and Stage 1&2 represent an increase in the number of minutes scored as those types of sleep.